What is the supplement FDA disclaimer?
The supplement FDA disclaimer is the statement a dietary supplement label must carry whenever it makes a structure/function claim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." FDA rules set its wording, placement and type size. It is a requirement, not a legal shield.
- The wording is fixed by 21 CFR 101.93(c); a plural version is allowed when there are several claims.
- On labels it must be in bold type at least 1/16 inch tall, next to the claim or linked by a symbol such as an asterisk.
- If not adjacent to the claim, it must be set off in a box, on every panel that carries a claim.
- It does not make a disease claim lawful or excuse unsupported advertising.
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What exactly must the disclaimer say and where does it go?
The disclaimer's text, placement and typography are all set by 21 CFR 101.93. Brands may not paraphrase it. The singular version reads: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." With several claims, "These statements have not been evaluated" may be used.
| Label rule | Requirement |
|---|---|
| Position | Immediately next to the claim, or linked to it by a symbol such as an asterisk |
| Every panel | Appears on each label panel or page that carries a claim |
| Box | If not directly adjacent, set off in a box |
| Type | Boldface, letters at least one-sixteenth of an inch tall |
The disclaimer is one of three requirements for a structure/function claim. The other two are substantiation and an FDA notification within 30 days of first marketing. See our structure/function claim entry.
Check label proofs for every package size. Small bottles and sachets are where type size and box placement most often slip.
How should brands handle the disclaimer on websites, marketplaces and social media?
The rule is written for labels and labeling, but most supplement brands carry the disclaimer wherever structure/function claims appear, because product pages and listings often function as labeling. Apply it consistently and ask counsel where your own obligations begin.
- Product pages: asterisk each claim and show the disclaimer close to the claims, not only in the site footer.
- Marketplace listings: include it in the description or bullet area where claims appear; listings on Amazon and other marketplaces have their own content rules as well.
- Email and SMS: where a message repeats a benefit claim, link it to the disclaimer.
- Video and social: on-screen text long enough to read, plus the caption.
- Influencer content: brief creators to use only approved claims; the disclaimer will not fix an improvised disease claim.
Our supplement and D2C health brand marketing team builds these rules into page templates so they are not left to each writer.
Keep one source for the disclaimer text in your site templates and listing tools so nobody retypes it. Retyped versions drift, and drifted versions no longer match the rule.
Why does the disclaimer matter for growth, and what does it not do?
Missing or malformed disclaimers are an easy issue for regulators, marketplaces and competitors to spot, and they can lead to listing removals or relabeling costs. Getting it right is cheap; getting it wrong can pause a launch.
What the disclaimer does not do matters more. It does not turn a disease claim into a lawful one. It does not satisfy the FTC, which expects competent and reliable scientific evidence for health claims under the FTC Health Products Compliance Guidance. And it does not let a brand imply FDA endorsement elsewhere on the page.
For how FDA labeling and FTC advertising rules fit together, read FTC and FDA rules for supplement advertising.
What disclaimer mistakes are most common?
- Rewording it, for example "not evaluated by FDA" or "consult your doctor" in its place.
- Putting it only in the footer, far from the claims.
- Using small or light type on packaging below the size and weight rules.
- Leaving claims without an asterisk on secondary panels.
- Relying on it to cover disease words in product names, images or hashtags.
- Placing it only inside an image, where search engines and screen readers cannot read it.
- Forgetting it on bundle pages, comparison charts and subscription upsells that repeat claims.
Audit regularly: crawl your site and listings for claim phrases, confirm each has its asterisk and nearby disclaimer, and fix templates before one-off pages.
Related pages from the US team
Supplement & D2C health brand marketing
Compliant growth for US supplement brands.
FTC and FDA supplement advertising rules
How labels and ads are regulated.
Structure/function claim
The claims that trigger the disclaimer.
US healthcare marketing glossary
Every term, defined in plain English.
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Common questions
What is the exact wording of the supplement FDA disclaimer?
The required wording is: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." When a label carries several claims, "These statements have not been evaluated" may be used. The text comes from 21 CFR 101.93(c).
When does a supplement need the FDA disclaimer?
A dietary supplement needs the disclaimer whenever its label or labeling makes a structure/function claim, such as describing how an ingredient supports normal body function. Products that make no such claims do not need it. Conventional foods making structure/function claims do not carry it either.
How big must the disclaimer be on a supplement label?
FDA requires the disclaimer in boldface type with letters at least one-sixteenth of an inch tall. It must sit next to the claim or be linked by a symbol such as an asterisk, appear on every panel bearing a claim, and be set off in a box if it is not adjacent.
Does the FDA disclaimer protect a brand from FTC action?
No. The disclaimer is a labeling requirement for structure/function claims. It does not make disease claims lawful and does not substitute for evidence. The FTC still expects health claims in advertising to be supported by competent and reliable scientific evidence.
A note on this guide: it explains marketing practice, not legal advice. Rules on privacy, advertising and insurance change and vary by state, so confirm anything compliance-related with your own counsel.
Are your product pages consistent with your labels?
Book a call with the US team. We will check claims and disclaimers across your site, listings and ads.